Biotechnological inventions and the Nagoya Protocol: how to avoid pitfalls?
The entry into force of the Nagoya Protocol is one of the objectives set by the Strategic Plan for Biological Diversity adopted in 2010 by the Parties to the Convention on Biological Diversity. The objective of this Protocol  is laudable but thinking to and meeting all requirements due, at every stage of the research and of the development of a product resulting therefrom, may turn out to be difficult, especially for patent applicants. Little reminder on these requirements...
1. Obtaining authorization to access the genetic resource and sharing the benefits arising from its use
As soon as a genetic resource is used for R & D purposes (for commercial intent or even non-commercial intent in some cases), it is needed to check:
- 1) if the source Country of this genetic resource is a party to the Nagoya Protocol, and
- 2) if this is the case, if the genetic resource used is one of the resources covered by this Protocol, certain exceptions existing, which may differ depending on the country .
If points 1 and 2 are satisfied, it is essential to obtain as soon as possible the prior informed consent of the country party to the Protocol from which the resource comes, based on which access to the resource will be given, and which may result in the issuance of a certificate of compliance.
For genetic resources from France, the decree of December 13, 2017 setting the standard contract for benefit sharing arising from the utilization of genetic resources taken from the national territory, provides a standard contract to formalize this prior informed consent negotiated between the future user and the French State (including for example the description of the resource, conditions for its use, conditions for benefit-sharing, conditions for publication of results and a clause on dispute settlement).
Access requests are then sent by email to the Ministry of Environment using appropriate forms , specifying inter alia the applicant, the description of the activities for which the request is made and their objective, the designation of the taxa concerned with the indication of the collection location or of the holding entity in case of the presence of the material in collections, the description of the technical methods of access to resources and the conditions of collection, the provisional calendar for carrying out the activities and the information considered confidential by the applicant.
A request for access to a genetic resource therefore implies an in-depth and early reflection on the intended use in the short and long term.
2. Statement of the use of the resource in the country Party to the protocol
Once the applicant has accessed the genetic resource, he must demonstrate by a statement, in the Countries where he uses it, that he exercised due diligence to ensure that access to the genetic resource was done in accordance with the provisions of the Protocol, this at different stages of research and/or development of a product based on this resource.
The form and especially the time to make this statement varies depending on the country. Yet, the fact of not making this statement in accordance with the national provisions can have disastrous effects both on the use of this resource and on the validity of the patents covering this use.
In France, this statement must be made:
- at the stage of research financing, if research has received external funding, when funding is received, by email to the Ministry of Research, g. with the model in Annex II of Commission Implementing Regulation (EU) 2015/1866;
- during the product final development, e.g. using the model in Annex III of Commission Implementing Regulation (EU) 2015/1866, before filing an application for approval or marketing authorization, before the notification required before the first placing on the Union market, before the placing on the Union market, or before the sale or transfer of the result to a third party (as the case may be), (i) by email to the French Patent Office, when this use leads to a patent application (without mentioning the application number or name of invention), (ii) to the competent authority for marketing, when this use leads to a request for marketing authorization, or (iii) by email to the Ministry of Environment.
The provision of this statement to the competent authorities is not anecdotal.
For example, in France, the use of genetic resources without having the information above when they are compulsory  is punished with one-year imprisonment and a fine of € 150,000 . The fine is even increased to one million euros in case of commercial use.
It is therefore vital to comply with the reporting requirements in the Countries where this resource is used.
3. National provisions linking the validity of a patent to compliance with the requirements of the Protocol
Failure to obtain authorization to access the resource has no impact on the examination procedure or the validity of a French or European patent. However, several countries have more or less demanding national provisions linking the validity or enforceability of a patent, for an invention based on the use of genetic resources, to compliance with the requirements of the Nagoya Protocol.
Depending on the country, the following information may be required at the time of filing or during the examination of the application: indication of the origin of the resource in the patent application, provision of specific forms to the Patent Office concerning the origin of the resource and the corresponding access numbers, filing of statements on the origin of the resources used, etc.
Brazil, China and India, for example, have very demanding requirements if a genetic resource obtained from their territory is the object of a patent application.
When filing a patent application relating to an invention arising from the use of a genetic resource, even if it is initially a French patent application, it is therefore essential to ensure that the Nagoya Protocol requirements for authorization of access to genetic resources have indeed been met.
The ideal is to provide as soon as possible the information concerning this authorization of access to your Patent attorney, so that he/she can ensure that all the information required in the different jurisdictions is available at the time of filing of the patent application and thus avoid rejections or invalidations of patents solely due to the failure to provide this information in due course.
Furthermore, the implementation of the Nagoya Protocol in countries Party to the Protocol is still in progress, and new countries are ratifying this protocol regularly. Accordingly, do not hesitate to consult your Patent attorney regularly concerning the specific requirements for filing a patent for an invention arising from the use of genetic resources. He/she will be able, with the help of his/her foreign agents, to provide you with this specific information, which is often not easily accessible...
 For example, in France, Decree 2019-916 excludes, on an experimental basis, for a period of 3 years, microorganisms in mainland France from the genetic resources concerned by the Protocol
 CERFA 15785*01 CERFA 15786 01* forms or by teleprocedure
 As well as and the fact of not seeking, keeping or transmitting this information to subsequent users
 Article L 415-3-1 of the Environment Code
- Publication date: February 2020
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